The entrusted test can be resorted to when the testing purpose cannot be realized by self-test, The entrusted testing institution should be certified. With respect to NMPA registration, the entrusted test can be considered as the pre-test of registration test at present. As a part of the biological evaluation, the biocompatibility test belongs to the entrusted test.
As specified in the Amendment for Regulations on the Supervision and Administration of Medical Devices (draft for review), the test report of the product can be the self-test report of the medical device registration applicant and recordation applicant, or the test report issued by a qualified medical device testing institution.
2. Service Contents and Process
Project startup---Process test application documents---Review technical requirements---Review method applicability and improve---Make a testing plan---Sample delivery---Start the test---Issue the test report.
This service complies with laws and regulations issued by relevant regulatory bodies. We can give guidance according to product information provided by the enterprise, and offer suggestions on test plan, time arrangement, sample delivery requirements, personnel requirements, rectification opinions, etc.
3. Tigermed-Jyton Testing Institutions
As a member to Tigermed-Jyton Group, Hangzhou Tiger Jyton Testing Technology Co., Ltd. is a third-party testing organization for medical devices, which is founded in accordance with GLP and CNAS standards and accredited by CNAS and CMA. Having nearly 2500 m2 professional laboratories, SPF animal laboratory, biology laboratory, physical chemistry laboratory, and electrical safety laboratory, etc., the company can provide entrusted test service for enterprises which have products with approved types and the needs of pre-test for registration test, biocompatibility test and other types of entrusted tests.
Since increasingly stringent requirements are imposed on the production quality system of medical devices, more and more attentions are paid to the verification of production process and production environment, the selection of materials, and quality control over outgoing products, etc. Our laboratories probides high-quality and efficient testing services for clients based on the principles of scientific, fair, accurate, standard, efficient and enthusiastic.
4. Team Introduction
More than 75% team members having a master degree or above
3 deputy senior engineers and above
5 laboratory certified internal auditors (ISO/IEC 17025: 2017)
10+ years’ experience of safety evaluation for medical devices
Working experience in Top 10 national inspection centers
Working experience in CFDA respiratory pharmacology laboratory
Experience in drug safety evaluation of Chinese Academy of Sciences
Working experience in world-renowned device/technical service companies
Amendment for Regulations on the Supervision and Administration of Medical Devices (draft for review)
Decision on Amending the Regulation on the Supervision and Administration of Medical Devices
No.680 Decree of the State Council
Administrative Measures for Medical Device Registration
No.4 Order of CFDA